FDA Issues Warning for CCSVI Treatment of MS Patients

We first heard of chronic cerebrospinal venous insufficiency (CCSVI) — a theoretic narrowing, or stenosis, of specific veins in the neck and chest (internal jugular and azygos veins) — in late 2009 and blogged about the topic in early 2010. I came out as a pretty harsh skeptic of the theory, but I have learned much since that time and have posted my thoughts on how to heal some of the rifts that the conversations we have led has caused.

Don’t get me wrong, I am still a skeptic, but a hopeful skeptic. An FDA Safety Communication issued yesterday affirms my skepticism, but does not quash my hope.

In very direct wording, the notice states, “The FDA is alerting people with MS to the risks of serious injuries and death associated with procedures to treat chronic cerebrospinal venous insufficiency (CCSVI). Furthermore, the benefits of these experimental procedures have not been proven, and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved.”

To the very existence of the condition CCSVI and its relationship to MS, FDA writes, “At this time, the FDA believes there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS. In addition, the criteria used to diagnose CCSVI have not been adequately established. Therefore, data to support CCSVI as a clinical entity on its own or its relationship with MS are inconclusive and at times, contradictory.”

They went on to list 5 specific areas of concern with the treatment for persons living with MS:

There is no clear diagnostic evidence that CCSVI exists as a distinct clinical disorder or is linked to MS.

Venous stenoses seen on imaging tests may be normal variants that do not cause any symptoms or disease, since they are sometimes seen in healthy people.

The safety and effectiveness of using balloon angioplasty devices or stents in the internal jugular or azygos veins have not been established for any clinical condition; nor has the FDA approved the use of these devices in these veins.

There is no clear scientific evidence that the treatment of internal jugular or azygos venous stenosis is safe in MS patients, impacts the symptoms of MS, changes the overall course of MS or improves the quality of life for MS patients.

It is possible that stent placement can worsen any venous narrowing. This is because further narrowing has been shown to sometimes occur within stents placed in veins, due to the body’s response to the implant.

Approvedresearch into evidence of CCSVI, correlation of CCSVI to MS, and possible treatment outcomes in MS Centers around North America with initial results expected within the next few months — I emphasize “Approved” research because one study was singled out by FDA and effectively shut down due to violations of FDA regulations of such studies.

The controversial CCSVI/MS debate will be studied by sociologists and medical ethicists for decades to come. That the first round of controlled clinical trials is soon to be published may bring answers for both sides of the debate. No matter the outcome, research will answer the question so we can either move on with treatment of this condition as part of multiple sclerosis, discard the theory as unrelated to MS, or some hybrid of the two.

Either way, science will answer the question well enough for most of us and we will all live with the lessons learned. That is why I am still hopeful…

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ABOUT THE AUTHOR

Trevis Gleason

Trevis L. Gleason is a food journalist and published author, an award-winning chef and culinary instructor who has taught at institutions such as Cornell University, New England Culinary Institute and...read more